NCT00408226

Safety Study of MKC-1 Combined With Pemetrexed to Treat Advanced Cancer and Non-Small Cell Lung Cancer

Phase 1/2 Study of Oral MKC-1 Administered Twice Daily for 14 Consecutive Days Every 3 Weeks in Combination With Pemetrexed

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: CASI Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the toxicities, maximum tolerated dose (MTD) and recommended phase 2 dose of MKC-1 when administered orally, twice daily for 14 days followed by 7 days without dosing, in combination with pemetrexed (delivered at its recommended single agent dose) to patients with advanced solid tumor malignancies. Also, to determine the antitumor activity, based on the objective response rate and median Progression Free Survival ("PFS"), of oral MKC-1, administered on this schedule in combination with pemetrexed to patients with non small cell lung cancer (NSCLC).

Conditions

• Advanced Cancer
• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	MKC-1	capsules, twice daily for 14 days in 21 day cycle
DRUG	pemetrexed	standard dosing of 500 mg/m2 infused every 21 days

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-06-01
• Completion: 2012-01-01
• First posted: 2006-12-06
• Last updated: 2012-01-20

Locations

4 sites across 1 country: United States